Seizure Drug May Treat Alcoholism
Study Shows Fewer Heavy Drinking Days for Patients Treated With Topamax
Oct. 9, 2007 -- The seizure and migraine medication Topamax shows promise
for treating alcohol dependence, a study shows. But use of the drug for this
purpose is not without controversy.
Alcohol-dependent patients in the University of Virginia study who took
Topamax for three and a half months averaged fewer heavy drinking days overall,
fewer drinks per day, and more days of continuous abstinence from drinking than
patients given placebo treatments.
The study was paid for by Topamax manufacturer Ortho-McNeil Neurologics, and
it appears in the Oct. 10 issue of TheJournal of the American
A spokeswoman for Ortho-McNeil tells WebMD that the company will not be
pursuing FDA approval for the drug as a treatment for alcohol dependence.
But in a letter to the FDA, the consumer interest group Public Citizen
accused the company of illegally promoting use of the drug for this
While doctors can legally prescribe FDA-approved drugs for nonapproved
conditions, it is illegal for the companies that market the drugs to promote
these so-called "off label" uses.
The Public Citizen complaint involved a question-and-answer sheet
distributed to the media before publication of the study, which specifically
discussed the drug's potential "off label" use for alcohol
Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing
about the question-and-answer sheet until the Public Citizen letter became
"Ortho-McNeil Neurologics does not support any reference to off label
use of its products and only promotes the use of Topamax in the approved
indication of migraine and epilepsy treatment," Russell says.
(What approaches have you tried to
quit drinking? What has worked best? Discuss it with others on WebMD's
Addiction and Substance Abuse: Support Group board.)
Fewer Drinks and Drinking Days
The study included 371 men and women with alcohol dependence. The men drank
35 or more standard alcoholic drinks per week prior to enrollment; the women
had 28 or more drinks. Participants' ages ranged from 18 to 65 with an average
of around 47.
A standard alcoholic drink was defined as one containing 0.5 ounces of
alcohol, which is found in a 10-ounce regular beer, a 4-ounce glass of wine, or
1 ounce of 100-proof liquor.
Study participants were treated with up to 300 milligrams of Topamax a day
or a placebo during the 14-week trial. Both groups had a weekly, 15-minute
session with a health care provider designed to promote adherence to
Only 5% of the Topamax users and 2.7% of the placebo users reported
attending Alcoholics Anonymous meetings during the study.
Compared with placebo treatment, treatment with Topamax was associated with
an 8% greater reduction in the percentage of heavy drinking days during the
trial, the researchers reported.
Researcher Bankole Johnson, MD, PhD, tells WebMD that alcoholics in the
trial who took Topamax went from the equivalent of drinking a bottle and a half
of wine a day to about 3 1/2 glasses of wine.